FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8962894
·
Received September 4, 2019
Report
- Report Number
- 3013756811-2019-56440
- Event Type
- Malfunction
- Date Received
- September 4, 2019
- Date of Event
- August 11, 2019
- Report Date
- September 4, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. ADDITIONALLY, THE CUSTOMER REPORTED THAT THE INSULIN GAUGE INTERMITTENTLY REFLECTED 0 UNITS WHEN THE CUSTOMER ATTEMPTED TO BOLUS, INDICATING THAT AN UNSPECIFIED CARTRIDGE ALARM HAD OCCURRED. BLOOD GLUCOSE RANGED FROM 243-499 MG/DL. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT COULD NOT IDENTIFY A SOURCE OF THE OCCLUSION. REPORTEDLY, CUSTOMER COMPLETED A SUPPLY CHANGE AND RESUMED INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 753674 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |